CE marks are certification marks indicating conformity with health, safety and environmental protection standards for products sold within the European Economic Area (EEA). CE marks are also found on products sold outside EEA manufactured in, or designed for sale, the EEA. This makes the CE mark recognizable throughout the world even for people who are not familiar with the European Economic Area. This is in a sense similar to the FCC Declaration of Conformity that is used on certain electronic devices sold in the United States.
The CE mark is a manufacturer's declaration that the product meets the applicable EC directives requirements.
This mark consists of the CE logo and, if applicable, a four-digit identification number from the Notification Board involved in the conformity assessment procedure.
"CE" originated in 1985 as an abbreviation of ConformitÃÆ' Â © EuropÃÆ' Â © enne , which means European Conformity , but it is not defined as such in the relevant legislation. The CE mark is a symbol of free marketing in the European Economic Area (Internal Market).
Video CE marking
Meaning
Existing in its current form since 1985, the CE mark indicates that the manufacturer or importer claims compliance with applicable EU laws applicable to a product, regardless of where it was manufactured. By affixing the CE mark to a product, the producer effectively declares, in its sole responsibility, conformity with all legal requirements to achieve CE marking enabling free movement and sale of products throughout the European Economic Area.
For example, most electrical products must comply with the Low Voltage Directive and EMC Directive; the toy must comply with the Toy Safety Rules. Marking does not indicate the creation of the EEA or that the EU or other authority has approved the product as secure or conformant. EU requirements may include safety, health and environmental protection, and, if established in any EU product law, assessments by Notified or Manufacturing bodies in accordance with a certified quality system of production. The CE mark also indicates that the product complies with directions related to "Electrical Magnetic Compatibility" - which means the device will function properly, without interfering with the use or functionality of other devices.
Not all products require CE marking to be traded in the EEA; only product categories are subject to the relevant directives or regulations that are required (and permitted) to obtain the CE mark. Most products marked CE may be placed on the market subject only to the control of the producer's internal production (Module A; see Self-certification, below), without independent examination of product conformity with EU law; The ANEC has warned that, among other things, CE marking can not be considered a "safety sign" for consumers.
CE marking involves self certification. Retailers sometimes refer to the product as "CE approved," but the sign does not actually show approval. Certain product categories require type testing by an independent body to ensure compliance with relevant technical standards, but the CE marking itself does not state that this has been done.
Maps CE marking
Countries requiring CE mark
CE marking is mandatory for certain product groups within the European Economic Area (EEA: 28 EU member states plus EFTA countries Iceland, Norway and Liechtenstein) plus Switzerland and Turkey. Manufacturers of products made within the EEA and importers of goods made in other countries shall ensure that goods marked CE comply with the standards.
In 2013, CE marking is not required by the countries of the Central European Free Trade Agreement (CEFTA), but members of the Republic of Macedonia, Serbia, and Montenegro have applied for membership of the European Union, and adopted many standards in the law (as did most former European Union member states of CEFTA joining the EU, before joining).
The rules underlying CE tagging
The responsibility for marking CE lies with anyone who places products on the market in the EU, ie EU-based producers, importers or distributors of products made outside the EU, or EU-based non-EU producer offices.
The manufacturer of a product affixes the CE mark to it but must take certain mandatory steps before the product can obtain a CE mark. The manufacturer shall make conformity assessment, prepare technical files and sign the Declaration established by the leading law for the product. Documentation must be available to the authorities on request.
The product importer must verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available upon request. The importer should also ensure that contact with the manufacturer can always be made.
Distributors should be able to demonstrate to the national authorities that they have acted cautiously and that they should have confirmation from the producer or importer that the necessary steps have been taken.
If an importer or distributor markets a product in their own name, they take over the responsibility of the manufacturer. In this case they should have sufficient information about the design and production of the product, as they will bear the legal responsibility when they affix the CE mark.
There are certain rules that underlie the procedure for affixing the sign:
- Products subject to specific EU directives or EU regulations that provide CE marks must be affixed with a CE mark before they can be placed in the market.
- Manufacturers should check, on their own account, the EU law to which they must apply for their products.
- Products may only be placed on the market if they comply with all applicable directives and regulations and if conformity assessment procedures have been carried out accordingly.
- Manufacturers prepare EU declarations on conformity or performance statements (for Construction Products) and affix a CE mark to the product.
- If specified in a directive or regulation, an authorized third party (Announced Body) must be involved in conformity assessment procedures or in regulating the production quality system.
- If a CE marking is affixed to a product, it may be marked additional only if it has different significance, do not overlap with the CE mark and are not confusing and do not damage the readability and visibility of the CE mark.
Since achieving compliance can be very complex, the assessment of CE compliance assessment, provided by the notified body, is critical throughout the CE marking process, from design verification, and the preparation of technical files to EU compliance declarations.
Guidelines for implementation of directives based on the New Approach and the Global Approach ("Blue Guides") were first published by the European Union in 2000. Updated versions were published on February 28, 2014 and July 26, 2016.
Self certification
Depending on the level of product risk, the CE mark is affixed to the product by the manufacturer or an authorized representative who decides whether the product meets all CE marking requirements. If a product has minimal risk, it can be self-certified by the manufacturer making the conformity statement and affixing the CE mark on their own product. To perform the certification, Manufacturers must do several things:
- 1. Determine if the product must have a CE mark. The product must comply with all Directives applicable to the product.
- 2. Select the conformity assessment procedure of the module called by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:
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- Module A - Control of internal production.
- Module B - Type EC checks.
- Module C - Compatibility for typing.
- Module D - Production quality assurance.
- Module E - Product quality assurance.
- Module F - Verify the product.
- G Module - Verify the unit.
- Module H - Full quality assurance.
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This will often ask questions about the product to classify the risk level and then refer to the "Conformity Assessment Procedure" chart. This indicates that all acceptable options are available for manufacturers to certify the product and affix the CE mark.
Products considered to be at greater risk should be independently certified by the notified body. This is an organization that has been nominated by the Member State and has been notified by the European Commission. These notified bodies act as test laboratories and carry out the steps outlined in the above-mentioned directives and then decide whether the product has passed. Manufacturers may elect their notified bodies in EU Member States but shall be independent of private sector or governmental organizations and organizations.
In fact the self-certification process consists of the following stages:
Stage 1: Identify Referrals that apply
The first step is to identify whether the product needs to be marked CE or not. Not all products are required to mark CE, only products that fall within the scope of at least one of the sectoral directives that require CE marking. There are over 20 sectoral product directives that require CE marking, but are not limited to, products such as electrical equipment, machinery, medical equipment, toys, pressure equipment, PPE, wireless devices and construction products.
Identifying which direction might be applicable, as there may be more than one, involves simple exercises reading the scope of each direction to establish what applies to the product (Example of Low Voltage Scope Instructions below). If the product is not included in one of the sectoral directives, then the product does not need to be marked CE (and, indeed, should not be marked CE).
Low Voltage Directive (2006/95/EC)
Article 1 states the Directive includes any "equipment designed for use with rated voltage between 50 and 1000 V for AC and between 75 and 1500 V for DC, other than the equipment and phenomena listed in Annex II."
Stage 2: Identify applicable requirements from Instructions (s)
Each Directive has a slightly different method to indicate suitability depending on the classification of the product and its intended use. Each Directive has a number of 'essential requirements' that the product must meet before it is placed in the market.
The best way to demonstrate that this essential requirement has been met is to meet the applicable 'harmonization standards' requirement, which offers a presumption of conformity to essential requirements, even though standard usage usually remains voluntary. Harmonious standards can be identified by searching for 'Official Journal' on the website of the European Commission, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardization Organizations.
Stage 3: Identify the appropriate route for customization
Although the process is always a self-declaration process, there are various 'route validations' for adjustments depending on the Directive and product classification. Some products (such as invasive medical devices, or fire and fire alarm systems) may, to some extent, have mandatory requirements for authorized third party involvement or "notified bodies".
There are various route validations that include:
- Product ratings by the manufacturer.
- Product assessment by the manufacturer, with additional requirements for a mandatory factory production control audit to be performed by a third party.
- Assessments by third parties (eg EC type tests), with requirements for mandatory factory production control audits to be performed by third parties.
Phase 4: Product conformity assessment
When all requirements have been established, the suitability of the product with the essential requirements of the Directive (s) needs to be assessed. This usually involves assessment and/or testing, and may include evaluating product conformity to the harmonization standards identified in step 2.
Stage 5: Compile technical documentation
Technical documentation, usually referred to as a technical file, relates to a product or various products need to be compiled. This information should cover every aspect relating to conformity and will likely include details on the design, development and manufacture of the product.
Technical documentation will usually include:
- Technical description
- Images, circuit diagrams, and photos
- List of materials
- Specifications and, if applicable, EU conformity declarations for important components and materials used
- Any design calculation details
- Test and/or rating report
- Instructions
- EU conformity statement
- Technical documentation may be available in any format (ie paper or electronic) and must be stored for a period of up to 10 years after the creation of the last unit, and in most cases in the European Economic Area (EEA)).
Stage 6: Create a declaration and add a CE mark
When manufacturers, importers or official representatives are satisfied that their products are in compliance with the Applicable Directive, the EU compliance statement must be completed or, for a part of the machine completed under the Machine Directive, an ECU incorporation statement.
Requirements for declarations are slightly different, but they will at least include:
- The manufacturer's name and address
- Product details (model, description, and serial number if applicable)
- List of applicable Sector Guidelines and applicable standards
- A statement stating that the product complies with all relevant requirements
- Signature, name and position of responsible person
- Date when the declaration is signed
- Details of official representatives in the EEA (if applicable)
- Additional instructions/custom standard requirements
- In all cases, except for the PPE Directive, all Directives can be declared on a single declaration.
- After the EU conformity declaration is completed, the final step is to put a CE mark on the product. When this has been done, the CE marking requirements have been met for products to be legally placed in the EEA market.
The purpose for security issues.
EU conformity declaration
EU compliance statements should include: manufacturer details (name and address, etc.); essential characteristics that the product adheres to; any European standards and performance data; if relevant identification number of the notified body; and legally binding signatures on behalf of the organization.
Product groups
Directives that require CE marking affect the following product groups:
- Implanted medical device (not including surgical instruments)
- Gas burning equipment
- Installation of power lines designed to carry people
- Construction products in accordance with Regulation (EU) no. 305/2011 under custom rule
- Eco-friendly design of energy products
- Electromagnetic compatibility
- Protective equipment and systems intended for use in potentially explosive atmospheres
- Explosives for civil use
- Hot water boiler
- In vitro diagnostic medical devices
- Lifting
- Low voltage
- Machine
- Measurement Instruments
- Medical devices
- Emission of noise in the environment
- Non-automatic weighing instrument
- Personal protective equipment
- Pressure tools
- Pyrotechnics
- Radio and telecommunication terminal equipment
- Recreational craft
- Restrictions on the use of certain hazardous materials in RoHS 2 electrical and electronic equipment
- Toy security
- Simple pressure vessels
Reciprocal recognition of conformity assessment
There are many 'Agreements on the Recognition of Mutual Conformity Assessment' between the EU and other countries such as the United States, Japan, Canada, Australia, New Zealand and Israel. As a result, CE marking is now found in many products from these countries. Japan has its own marker known as the Technical Conformity Mark.
Switzerland and Turkey (which are not EEA members) also require products to bear CE marking as affirmation of conformity.
Characteristics of CE marking
- The CE marking must be affixed by the manufacturer or its authorized representative in the European Union in accordance with its visible, unreadable and indelible legal format on the product
- When a manufacturer places a CE mark on a product, this means that the product complies with all essential Health and Safety requirements of all directives applicable to its product.
- For example, for a machine, Machine directive applies, but often too:
- Low voltage directives
- EMC directive
- sometimes other directives or rules, e.g. ATEX directives
- and sometimes other legal requirements.
- For example, for a machine, Machine directive applies, but often too:
When the manufacturer of a machine places a CE mark, it binds itself and warrants that it makes all tests, assessments and evaluations on the product to meet all the requirements of ALL directives applicable to its products.
- CE marking was introduced by DIRECTIVE COUNCIL 93/68/EEC July 22, 1993 which changed Directive 87/404/EEC (simple pressure vessel), 88/378/EEC (safety toy), 89/106/EEC (89), 89/392/EEC (machine), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic ballast instruments), 90/385/EEC (implantable drug device), 90/396/EEC (gas fuel combustion equipment), 91/263/EEC (telecommunication terminal equipment), 92/42/EEC (newly fired hot water boilers with liquids or materials fuel gas), 93/42/EEC (medical device) and 73/23/EEC (electrical appliances designed for use within certain voltage limits)
- The size of the CE mark should be at least 5 mm, if the proportion is enlarged to be maintained
- If the appearance and workmanship of the product does not allow the CE mark to be affixed to the product itself, the marking should be affixed to the packaging or the accompanying document
- If the instructions require the Verified Agency's involvement in the conformity assessment procedure, its identification number should be placed behind the CE logo. This is done under the responsibility of Notified Body.
E mark
In motor vehicles and related parts, the UNECE " e " or " E " flag, rather than the CE Logo, should used. Contrary to the CE logo, the UNECE mark does not certify itself. They should not be confused with the estimated marks on the food label.
Abuse
The European Commission recognizes that CE marking, like any other certification mark, is misused. CE marking is sometimes attached to products that do not meet legal requirements or conditions, or are affixed to unnecessary products. In one case it was reported that "Chinese manufacturers deliver well-engineered electrical products to obtain conformance testing reports, but then remove non-essential components in production to reduce costs". A test of 27 electric chargers found that all eight of the legitimate brands with reputable names met the security standards, but none of them were unbranded or with the first name to do so, despite signs; non-compliant devices are potentially unreliable and dangerous, presenting electrical and fire hazards.
There are also cases where the product meets the applicable requirements, but the shape, dimensions, or proportions of the mark itself are not as specified in law.
Spark plugs and domestic sockets
Directive 2006/95/EC, "Low Voltage" Directive, exclusively excludes (i) plugs and socket outlets for domestic use which are not covered by any Union directive and therefore may not be marked CE. Across the EU, as in other jurisdictions, control of plugs and outlet sockets for domestic use is subject to national regulations. However, illegal use of CE marks can be found on domestic plugs and sockets, especially the so-called "universal sockets".
Chinese Export
A logo very similar to CE marking has allegedly stood for Chinese Exports as some Chinese manufacturers apply it to their products. However, the European Commission says that this is a misunderstanding. The problem arose in the European Parliament in 2008. The Commission replied that they were unaware of the existence of the "Chinese Export" sign and that, in his view, the incorrect application of the CE mark on the product was not associated with a misrepresentation of symbols, even though both practices occurred. It has initiated procedures to register CE marking as a collective trademark of the Community, and is in discussion with Chinese authorities to ensure compliance with European legislation.
Legal implications
There is a mechanism to ensure that CE markings are placed on the product correctly. Controlling products marked with CE is the responsibility of public authorities in member countries, in cooperation with the European Commission. Citizens may contact the national market supervisory authorities if abuse of the CE mark is suspected or if product safety is questioned.
The procedures, actions and sanctions applied for counterfeiting of CE marks vary according to national and criminal law laws of each member country. Depending on the seriousness of the crime, the economic operator may be fined and, in some circumstances, a prison. However, if the product is not considered an urgent security risk, the manufacturer may be given the opportunity to ensure that the product complies with applicable law before being forced to remove the product from the market.
See also
- Country of origin
- FCC Declaration of Conformity
- Kitemark
References
External links
- European Commission: Blue Guides
- How to reproduce the CE mark
- CE marks the EUROPA website
- CE Marks the construction product
- EU directives and regulations for CE marking
Source of the article : Wikipedia
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